ISO 13485:2016 – Creating a Glass Ceiling for Startups

May 2016 was a dark day for medical small companies and startups, it was the day the ISO created a glass ceiling for Medical Startups.

A glass ceiling! Yes, because ISO13485:2016 essentially puts a glass ceiling on medical start-ups with a daunting new array certification requirements that will disproportionally impact startups and small companies. Essentially, to properly manage and administrate the new ISO13485:2016, requires a rather substantial team dedicated to the task and a lot more of the founders time and effort.

Medical device startups now need to be of a certain size and girth to be able to handle the additional plethora of bureaucratic layering all in the name of documented quality. Will this documented approach assure quality in these startups, make no mistake, it will NOT!

Born in Europe, the ISO reflects the bureaucratic approach to quality management. The more managers, the more the quality must be good… How can this be wrong?

The new medical device standard, ISO13485:2016 is more at home in larger corporations where there are many different, and often conflicting, layers of management and various ivory towers of influence that must be brought together to deliver any product. Where control is yielded not for the purpose of quality but for ego’s, budgets and access to other corporate resources.

A founder's driven startup has no such structural problems.

In start-ups, John the engineer is sitting next to you and you can lean over and ask about a problem. In the new ISO Standard, you and John now need to have a meeting, take minutes, record notes… then you need a manager, essentially you, to review and approve them. With an average number of 8 persons in a start-up, who in the start-up is left to be the QMS manager… the receptionist? The receptionist in today’s startup is likely to be a virtual person. So back to the original question, who is left to take on the many roles being promulgated as the epitome of QMS.

For startups there simply is no human bandwidth left, especially qualified to do this properly.

What the new ISO 13485:2016 does is give the TUV’s of the world, a.k.a. 3rd party accreditation agencies, far too much power to dictate and sidetrack any approval, there are simply too many potential obstacles that can now befall the startup. For 3rd party accreditation industry ISO 13485:2016 is a gift of revenue… for years and years to come…

Admittedly the intent of the Standard was to create safer medical devices - a just and noble intent that nobody is going to challenge. The belief was that if you can document all the problems from design to production it will lead to better safer devices. Safety and effectiveness, however, is not measured in the number of documents you produce. Sadly, this is the inevitable outcome of this updated new standard.

The new standard evidently panders to elements of the FDA’s QSR’s (Quality System Regulations) in a bid to attract and entice the FDA to adopt them - after all, with this new standard, are they not now basically the same?

Well no because the single most essential element is ISO imposes 3rd party accreditation whereas FDA does not. And wisely so. The FDA has justifiably refused to pander to this sirens song.

Let’s face it, essentially, the FDA played this one really smart. It recognized that startups are less likely to be able to handle 3rd party accreditations not only because of the costs and financial burden it can impose on the startup but also on the negative impact on innovation.

Case in point is Canada

Since imposing ISO 13485:2003, the number of medical startups has plummeted. Bureaucracy or layers of management paperwork kills innovation. In a remarkable recognition of said failed policy, Health Canada has put on its website a remarkable, even impressive, array of documentation to help startups and small companies navigate ISO13485:2003. Its still a failed attempt to assist innovation startups to get through the bureaucratic quagmire.

Sadly, it has not helped. Rather, the exodus of Canadian Innovators continues, whether they move to the US or simply sell only to the USA and avoid Canada altogether.

This outcome is detrimental to all Canadians.

Canadians Innovators can and do meet the QSR regulations but the onerous burden of 3rd party accreditation is a glass ceiling upon innovation in Canada, and everywhere it is imposed.

Yes, that’s right, Canadians innovators, Startups, won’t even try to sell within Canada - too many Health Canada rules, the result of ISO13485 being made a mandatory requirement before they can even apply for certification by Health Canada.

The results are predictable, only large companies, able to field a large ISO team, only they can sell in Canada - and Canadians wonder why medical device prices in Canada are so much higher than those in the USA.

Duh!

But the real kicker is that if you apply for government innovation funding, ISO13485 assistance is deliberately EXCLUDED! They cause the injury but don't provide band-aids.

Europe has seen the same phenomenon. As a direct result of ISO13485-2003, there are few medical startup innovation companies in existence in Europe - that is those not being financed by Horizon2020 or some other waste prone “research” or “innovation” euro funds.

Albeit well-intentioned, the bureaucratic juggernaut of incompetence that has taken over makes a sham of the EU funding system with secret decisions impossible to decipher or challenge, and where awards are based on selecting companies based on their knowledge of marketing 101… as anything more advanced only confuses the bureaucrats. But at least in Horizon2020, ISO13485 financing assistance is in theory possible (but only big companies need to apply).

How to understand the glass ceiling that is ISO13485:2016

First, most startups have between 8-12 people in them. To do all the tasks and requirements imposed would require 4 of them, minimum, to be dedicated to this alone. So who is left to do the research, the innovation, the engineering, the payroll?

Second, the nature of the startup is to aim for growth… innovate and grow, or die. Timing is usually a critical factor, as the shelf life of any innovation is often very short and copy-cats abound, particularly in Russia and China, these guys simply don’t play fair and certainly not by the rules. Adding a lot more rules makes it exponentially more difficult for startups to get a market advantage, not because they cannot innovate or because they cannot do quality, but because a TUV requires a minimum of 6 months operations before they will even entertain the idea of accreditation. The new ISO 13485:2016 will certainly require 1-2 years “in play”.

Third, startup persons tend to be innovators, not bureaucrats. The expertise is often in the founders themselves, which is expressed as infectious enthusiasm to succeed through innovation. The development team is limited and the knowledge closely held by them. The secret sauce cannot be revealed. The critical element at this stage of the startup is the risk assessment, not the production of the device. There are other specialist’s companies that can produce the device correctly, but 2016 imposes a whole new dimension of supply-chain responsibility and validation.

Lastly, startups operate on less than sufficient funds, and budgets will focus on the innovation and getting to market. Its only natural, especially in a small focused team environment where resources are scarce to focus on the essential quality, not the process of quality. That formal process of quality, ISO13485:2016, is subordinated to the informal team-based approach to quality - there simply is not enough money around to wait half a year to maybe get a TUV to even bother to consider looking at you. The TUV’s have bigger fish to fry and those fish have deeper pockets the TUV’s can pick.

Make no mistake, for startups, ISO13485:2016 expansion of its quality requirements not only imposes a glass ceiling, it quadruples the thickness of the glass ceiling.

So how can startups hope to cope?

QMS solutions for small businesses or companies, much fewer startups, are few and far between. They are usually paper-based, or the better ones PDF based and all are costly and cumbersome. But the qmsWrapper solution stands out, focusing not so much on the paperwork but on the processes from which ISO 13485:2003 and 2016 are founded upon, QMS processes.

By focusing on QMS processes, qmsWrapper targets how startups and small companies actually work, not adding to their work. We call it Management Through Quality(tm)or MTQ, our solution is using the aims of quality as management reporting points within the work process. qmsWrapper promulgates a team-based cooperative compliance approach that enables each member of the team to make their own contribution to compliance, such that the small efforts by each, accumulate to a systemic and more complete strategy. Rather than burden a few with all the responsibility of Regulatory and ISO standards compliance, MTQ empowers each member of the team to be a QMS contributor, a wrapper around compliance and QMS.

For Startups and smaller innovation companies, MTQ means they can address many of the requirements of ISO13485:2016, and of 2003 as well, without turning half the company into QMS managers.

This wrapper approach just might well be the sonic boom that can help weaken the glass ceiling and free medical startup innovation of the burden of compliance, whether of ISO 13485:2016 or of FDA’s QSR’s.

Having to live through both systems, I respect the FDA for not folding to ISO’s siren song. Medical device innovation is already difficult enough without hiring another layer of management. MTQ is a wrapper to innovation. Streamline the way you approach compliance, use qmsWrapper.